Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis (DESTIN)

Orlando Health, Inc.

Status: Active, not recruiting

Conditions: Pancreatitis,Acute Necrotizing

Treatments: Procedure: Step-up endoscopic interventions; Procedure: Immediate endoscopic necrosectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05043415

21.067.05

1746067 (Other Identifier)

Details and patient eligibility

About

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

Full description

In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.

However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or over
2. Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
3. Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
4. Necrotic collection visualized on EUS and amenable to EUS-guided drainage

Exclusion criteria

1. Age < 18 years
2. Females who are pregnant
3. Necrotic collection that is not amenable for EUS-guided drainage
4. Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
5. Use of anticoagulants that cannot be discontinued for the procedure
6. Unable to obtain consent for the procedure from either the patient or LAR

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Immediate endoscopic necrosectomy

Active Comparator group

Description:

Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Then in this group, endoscopic necrosectomy will be performed immediately following index EUS-guided drainage of the necrotic collection, during the same session

Treatment:

Procedure: Immediate endoscopic necrosectomy

Step-up endoscopic intervention

Active Comparator group

Description:

Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. In this group, only EUS-guided drainage of the necrotic collection will be performed, and endoscopic necrosectomy will be performed at a separate session at a later time as needed.

Treatment:

Procedure: Step-up endoscopic interventions